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Clinical-stage biotechnology market forecast to reach $97.12 billion by 2030
The clinical-stage biotechnology market is projected to grow at a compound annual growth rate of 15.5%, reaching a valuation of $97.12 billion by 2030. Key drivers include increased investment in late-stage trials, demand for innovative therapeutics, and the adoption of digital tools. The market is segmented by product type, development phase, application areas, and end-users. Notable developments include BioNTech SE's acquisition of CureVac N.V. in June 2025 and Ichor Life Sciences Inc.'s launch of clinical trial services in November 2023. Major players include Sarepta Therapeutics Inc., PTC Therapeutics Inc., and Evotec SE.
FDA moves toward real-time review of clinical trial data
The US Food and Drug Administration is implementing real-time clinical trial reviews using AI and cloud computing to accelerate drug development. This initiative allows regulators immediate access to safety signals and endpoints, aiming to reduce the typical 10-12 year approval timeline. Two proof-of-concept cancer studies with AstraZeneca and Amgen are currently underway as part of this push, utilizing Paradigm Health platforms. The FDA seeks public input on the broader pilot program, with selection criteria expected in July.
EMA pilot programme for breakthrough medical devices applications open
The European Medicines Agency (EMA) has opened applications for its pilot programme providing expert panel advice for developers of breakthrough medical devices and in vitro diagnostic medical devices. The first phase, targeting Class III and Class IIb active devices, accepts submissions until 22 May 2026, with a focus on cardiovascular and paediatric devices. Five applications will be selected for initial assessment. The programme aims to test adaptive certification procedures proposed in the revision of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).